BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3

    MDR report key: 1022519 · Received March 24, 2008

    Report

    Report Number
    9681821-2008-00015
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 25, 2008
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM]. PEN WAS LEAKING [DEVICE FAILURE] ([BLOOD GLUCOSE INCREASED]). CASE DESCRIPTION: MEDICAL DEVICE INFO: CLASS IIB. THIS SPONTANEOUS REPORT, RECEIVED FROM A CONSUMER IN THE UNITED STATES AND REPORTED AS "PEN WAS LEAKING AND HIGH READINGS", CONCERNS A (B) (6) MALE PT TREATED WITH NOVOPEN 3 INSULIN DELIVERY DEVICE, (FIRST USE UNK TO ONGOING) FOR "INSULIN-REQUIRING TYPE II DIABETES MELLITUS". THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B) (6) 2008, WHILE USING THE PRODUCT IN QUESTION. THE PT REPORTED THAT THE NOVOPEN 3 WAS LEAKING AND THAT THERE WAS NO RESISTANCE WHILE DEPRESSING THE PUSH BUTTON. THE PT SUBSEQUENTLY EXPERIENCED HIGH BLOOD SUGAR READINGS AND HIS WIFE TRANSPORTED HIM TO THE EMERGENCY ROOM WHERE HE RECEIVED TREATMENT WITH INTRAVENOUS SODIUM CHLORIDE. THE EVENT RESOLVED A FEW HOURS LATER AND THE PT WAS DISCHARGED FROM THE EMERGENCY ROOM. NOVOPEN 3 THERAPY WAS CONTINUED AND HIS PHYSICIAN PRESCRIBED NOVOLOG INSULIN (RAPID ACTING INSULIN ASPART) UPON DISCHARGE. THE OVERALL OUTCOME IS REPORTED AS "RECOVERED". REPORTER'S CAUSALITY: UNK. NOVO NORDISK CAUSALITY: REPORTABLE. COMPANY COMMENT: THIS IS AN INITIAL REPORT AND FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA SSCN477

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SUSPENSION FOR INJECTION, 100 IU/ML| METFORMIN (METFORMIN)| NOVOLIN 70/30 (INSULIN HUMAN)